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2,241 stories matching this filter · ← front page

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  • Beam Therapeutics reports early Phase 1/2 data for base editing therapy in GSD Ia, partners with Pfizer and Enodia
    Beam Therapeutics disclosed early results from a Phase 1/2 study evaluating a base editing approach aimed at correcting the genetic defect that causes glycogen storage disease type Ia, a rare metab…
    Endpoints · 27d agoPositive readoutNeutral↗ source
  • Par Health initiates voluntary recall of Argatroban injection after detecting particulate contaminants
    Par Health USA announced a voluntary nationwide recall of its Argatroban Injection 250 mg/2.5 mL product, affecting 22 lots that have been distributed to hospitals and users. The recall was trigge…
    fda recalls · 27d agoRegulatoryNegative↗ source
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Nephrology758
  • Saudi Arabia signs 46 biotech agreements at Riyadh summit, targeting $1.5 bn investment
    The fourth Riyadh Global Medical Biotechnology Summit wrapped up on September 16, with 46 agreements signed among local and international participants. The disclosed agreements represent about 5.5…
    Fierce Biotech · 27d agoDealPositive↗ source
  • Paragon Labs launches ninth biotech, Velaris Therapeutics, via reverse merger to bring cardiopulmonary drugs to Alaunos
    Paragon Labs announced the creation of its ninth biotech company, Velaris Therapeutics, using a reverse‑merger approach it has refined over the past four years. The transaction was completed on Tu…
    Endpoints · 27d agoDealPositive↗ source
  • WCG launches AI-driven Activation Intelligence to speed clinical trial start-ups
    WCG, a provider of clinical trial solutions, announced a new AI-powered program called Activation Intelligence aimed at accelerating the start-up phase of studies. In early access, the tool report…
    Fierce Biotech · 27d agoPositive↗ source
  • Insulet launches full U.S. release of Omnipod Discover data platform for Omnipod 5 users
    Insulet announced that its Omnipod Discover platform is now fully available across the United States. The web-based service is built to work with the company’s Omnipod 5 automated insulin delivery…
    Fierce Biotech · 28d agoPositive↗ source
  • Novartis secures supplemental FDA approval to market repurposed antibiotic Lamprene in the US
    Novartis has obtained a supplemental approval from the U.S. Food and Drug Administration for its drug Lamprene, allowing it to be sold as an antibiotic. Lamprene, originally developed decades ago…
    Endpoints · 27d agoApprovalPositive↗ source
  • BioNTech's head and neck cancer vaccine fails to meet first primary endpoint in pivotal trial
    BioNTech reported that its experimental mRNA vaccine targeting head and neck cancer did not achieve one of the two primary goals in a pivotal study. The trial was designed to evaluate the vaccine’…
    Endpoints · 27d agoNegative readoutNegative↗ source
  • Readily secures $11 million to expand AI compliance platform for insurers
    Readily, a San Francisco‑based startup, uses artificial intelligence to monitor and flag changes in government regulations that affect insurance companies. The company announced it has closed an $…
    Endpoints · 27d agoDealPositive↗ source
  • Rudy Tanzi says he may be nearing a cheap, safe Alzheimer’s prevention pill
    Rudolph Tanzi has spent decades pursuing a way to stop Alzheimer’s disease before it starts. As a leading researcher, he has long spoken about the need for a simple, widely accessible solution. T…
    Endpoints · 27d agoPositive↗ source
  • Former Apogee Therapeutics leaders join Paragon Labs to expand R&D and company creation platform
    Michael Henderson, who previously led Apogee Therapeutics, is now serving as chief executive officer of Paragon Labs. He is accompanied by five other former Apogee executives who have moved to Par…
    Endpoints · 27d agoPositive↗ source
  • Paragon Labs hires former Apogee leadership after AbbVie acquisition and spins out hypertension unit
    Paragon Labs announced it has brought several former Apogee Therapeutics executives onto its senior team following AbbVie's $10.9 billion purchase of Apogee. The incoming leaders include Michael H…
    Fierce Biotech · 28d agoDealNeutral↗ source
  • FTC and seven states seek contempt order against Martin Shkreli for breaching lifetime pharma ban
    Martin Shkreli is again under investigation by the Federal Trade Commission. The FTC, together with seven states, filed a petition in a New York federal court asking that Shkreli be held in contem…
    Endpoints · 27d agoRegulatoryNegative↗ source
  • Health tech firms expand AI scribing tools toward prescribing and billing functions
    Health technology companies are accelerating development of artificial‑intelligence driven scribing solutions that can be deployed across health systems. While early versions focused on documentin…
    Endpoints · 27d agoNeutral↗ source
  • Syndax halts development of Niktimvo after Phase 2 failure in IPF trial
    Syndax announced it is stopping work on its experimental drug Niktimvo for idiopathic pulmonary fibrosis (IPF) after the compound did not meet its primary endpoints in a placebo-controlled Phase 2…
    Endpoints · 27d agoNegative readoutNegative↗ source
  • Nurix halts development of BTK degrader zelebrudomide after phase 1 review
    Nurix announced it will discontinue clinical development of its BTK degrader zelebrudomide, also known as NX-2127, following completion of enrollment in a phase 1 trial for aggressive non‑Hodgkin l…
    Fierce Biotech · 28d agoNegative↗ source
  • Pan Pepín recalls Para Bien Al Grano cereal batches over undeclared sesame allergen
    Pan Pepín Inc., based in Bayamón, Puerto Rico, issued a voluntary recall of certain lots of its Para Bien Al Grano product after discovering that sesame, an undeclared allergen, is present. The co…
    fda recalls · 27d agoCRLNegative↗ source
  • Pan Pepin recalls Para Bien Al Grano boxes after discovering undeclared sesame
    Pan Pepin Inc., based in Bayamón, Puerto Rico, announced a recall of certain lots of its 24‑oz Para Bien Al Grano product because sesame was present but not listed on the label. The undeclared ses…
    fda recalls · 27d agoCRLNegative↗ source
  • BMS reports phase 3 successes in IPF drug and neuroendocrine tumor radiotherapy
    Bristol Myers Squibb announced that two of its phase 3 trials have met primary endpoints, marking important milestones as the company seeks growth beyond its patent expirations. The Aloft-IPF stud…
    Fierce Biotech · 29d agoPositive readoutPositive↗ source
  • Mirum's Livmarli cuts itching in ultra-rare liver disease trial, showing significant benefit
    Mirum Pharmaceuticals reported that its ileal bile acid transporter inhibitor Livmarli achieved a statistically significant reduction in cholestatic pruritus compared with placebo in a late‑stage s…
    Endpoints · 28d agoPositive readoutPositive↗ source
  • Asahi Kasei Therapeutics receives FDA approval for HSV drug acquired in $1 billion deal
    Asahi Kasei Therapeutics announced that the U.S. Food and Drug Administration granted approval for its herpes simplex virus (HSV) therapy. The drug, called Hovilpri, was purchased by Asahi Kasei e…
    Endpoints · 28d agoApprovalPositive↗ source
  • Roche reports updated eye drug data and FDA filing acceptance, targets July 2027 decision
    Roche Genentech has presented new data from its eye disease trials, a year after a mixed Phase 3 readout, and noted that the FDA has accepted its filing for vamikibart with a decision slated for Ju…
    Fierce Biotech · 29d agoRegulatoryPositive↗ source
  • Bristol Myers reports two Phase 3 successes for fibrosis and RayzeBio drug
    Bristol Myers Squibb announced Monday that two of its late-stage trials have met primary endpoints. The first trial involved its fibrosis program, where the experimental therapy demonstrated the e…
    Endpoints · 28d agoPositive readoutPositive↗ source
  • GSK allocates over $800 million to expand R&D and manufacturing hub in Pennsylvania
    GSK announced it will invest more than $800 million to expand its presence in Pennsylvania, marking its second expansion in the state within two years. The funds will be used to build a new resear…
    Endpoints · 28d agoDealPositive↗ source
  • Tortugas Neuroscience's obuprazine shows significant improvement in phase 2b schizophrenia trial in China
    Tortugas Neuroscience, a biotech founded by former Sage Therapeutics staff with $106 million in funding, reported positive data from a phase 2b study of its schizophrenia candidate obuprazine, lice…
    Fierce Biotech · 29d agoPositive readoutPositive↗ source